CClinicalTrials.gg
Sign In
CompletedNCT03052309Updated Aug 15, 2022

BIOLUX P-III BENELUX All-Comers Registry

An observational study in Peripheral Arterial Disease, sponsored by Biotronik AG. Completed at 9 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-15.

Sponsored by Biotronik AG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
106
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal arteries

02

Conditions studied

  • Peripheral Arterial Disease
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 106 is below the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Biotronik AG is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The BIOLUX P-III BENELUX registry will include subjects from an all-comers patient population with all subjects requiring popliteal artery revascularization with the Passeo-18 Lux DCB

Inclusion criteria

  • Age ≥ 18 years or minimum age as required by local regulations
  • Subject must be willing to sign a Patient Data Release Form (PDRF) or Patient Informed Consent (PIC) where applicable
  • Lesion(s) in the popliteal arteries suitable for endovascular treatment, treated with or scheduled to be treated with the Passeo-18 Lux drug coated balloon.
  • Isolated popliteal artery lesion: at least 2 cm of healthy segment between lesion(s) in the popliteal artery and lesion(s) in distal superficial femoral artery
  • Inflow free from flow-limiting lesion. Patients with flow-limiting inflow lesions (> 50% stenosis) can be included if lesion(s) have been treated successfully before or during the index procedure, with a maximum residual stenosis of 30% per visual assessment
  • At least one native artery with direct outflow artery to the foot
  • Rutherford classification 2-5
  • Patient with bypass surgery in the same limb can be enrolled if there is at least 2 cm healthy segment between popliteal artery and anastomosis

Exclusion criteria

Exclusion Criteria:

  • Life expectancy ≤ 1 year
  • Rutherford classification 6
  • Lesion involving the superficial femoral artery (arterial intersection with the femur in an anteroposterior view) or extending in infra-popliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk)
  • Aneurysm at the level of the popliteal artery
  • Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations)
  • Intraprocedural decision not to proceed with the Passeo18 Lux DCB for any reason not related to the device (for instance blood flow limiting dissection after predilatation)
  • Subject is currently participating in another investigational drug or device study that has not reached its primary endpoint yet
  • Subject is pregnant or planning to become pregnant during the course of the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
106 participants (actual)
Patient registry
No

Interventions

  • DevicePasseo-18 Lux DCB

    The decision to treat the patient with Passeo-18 DCB is at the investigator discretion. The endovascular procedure is performed as per standard of care and device Instructions For Use (IFU)

06

What researchers measure

Primary outcomes

  1. Freedom from Major Adverse Events (MAE)

    Freedom from Major Adverse Events (MAE): A composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR)

    Time frame: 6 months

  2. Freedom from clinically driven target lesion revascularization (cd-TLR)

    Any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.)

    Time frame: 12 months

Secondary outcomes

  1. Freedom from clinically-driven target lesion revascularization (cd-TLR)

    Time frame: 6 and 24 months

  2. Freedom from clinically-driven target vessel revascularization (TVR)

    Time frame: 6, 12 and 24 months

  3. Primary patency

    freedom from \>50% restenosis in the target lesion as indicated by a duplex ultrasound peak systolic velocity ratio (PSVR) \>2.5 or by visual assessment of an angiogram with no clinically driven re-intervention

    Time frame: 12 and 24 months

  4. Freedom from Major Adverse Events (MAE)

    Freedom from Major Adverse Events (MAE): A composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR)

    Time frame: 12 and 24 months

  5. Change in mean Ankle Brachial Index (ABI)

    compared to the pre-procedure

    Time frame: 6, 12 and 24 months

  6. Improvement in Rutherford classification

    compared to the pre-procedure Rutherford classification

    Time frame: 6, 12 and 24 months

  7. Amputation-free survival (AFS)

    including major, minor and overall AFS

    Time frame: 6, 12 and 24 months

  8. Pain score

    compared to the pre-procedure score.

    Time frame: 6, 12 and 24 months

  9. Walking Impairment Questionnaire

    compared to the pre-procedure score.

    Time frame: 6, 12 and 24 months

  10. Device success

    Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB

    Time frame: immediately upon index procedure

  11. Technical success

    Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation

    Time frame: immediately upon index procedure

  12. Procedural success

    Procedural success is technical and device success without the occurrence of any MAE (as defined in the protocol) during the hospital stay

    Time frame: immediately upon discharge

07

Study locations

9 sites
  • Ziekenhuis Oost Limburg Genk
    Genk, Belgium
  • University Hospital Gent (UZ Gent)
    Gent, Belgium
  • Algemeen Ziekenhuis Groeninge Kortrijk
    Kortrijk, Belgium
  • Algemeen Ziekenhuis Delta Roeselare
    Roeselare, Belgium
  • AZ Portaels
    Vilvoorde, Belgium
  • Centre Hospitaliers Luxembourg
    Luxembourg, Luxembourg
  • OLVG
    Amsterdam, Netherlands
  • Maasstad Ziekenhuis
    Rotterdam, Netherlands
  • Maxima Medisch Centrum Veldhoven
    Veldhoven, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03052309
Lead sponsor
Biotronik AG
Responsible party
Sponsor
First posted
Feb 14, 2017
Start date
Feb 24, 2017
Primary completion
Jun 9, 2020
Completion
Apr 27, 2021
Last update
Aug 15, 2022

Study contacts

Franck Vermassen
principal investigator · UZ Gent
JGAM Blomjous
principal investigator · OLVG Amsterdam

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Peripheral Arterial Disease→

Other studies from this sponsor

Biotronik AG

Start the discussion